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To: NativeSon
Your post makes excellent sense. I had 3 surgical procedures that entailed the use of heparin. This was 2 years ago, and I am grateful that the timing was fortuitous in regards to the contamination.I was completely dependent on the hospital's judgment and supply of anticoagulants. The cost cutting imperatives of US pharmaceuticals will have to be balanced by legislation, it seems. As much as I hate to say it, this is one of those cases where government intervention seems warranted. The market mechanism has cost lives.
6 posted on 05/01/2008 4:55:52 AM PDT by zeller the zealot (Are Republicans the Party of Life, or is that too risky?)
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To: zeller the zealot
As much as I hate to say it, this is one of those cases where government intervention seems warranted. The market mechanism has cost lives.

You don't have to feel bad about having the gug'mint on this. they are supposed to be in on this - the FDA. CFR Title 21 GMP's.

There are rules when you use/manufacture/import/decant/repackage/test API's (Active Pharmaceutical Ingredients).

The importer of record should have tested this material to spec. ( USP monograph).

The problem is that there are a huge number of hands that the material passes through before use. By the time it( China origin API) gets to the domestic manufacturer, it looks (on paper at least) that it came from a friendly, US FDA inspected, cGMP Compliant, ISO blessed, neighborhood Pharma that has been in the US for 100 years.

so it must be ok...

"Rules of Origin" play a big role in this deception. If you use trade rules, eventhough a raw chemical/API comes from China, if you import it into the US, and add a lot of value (Net Cost calc in NAFTA) or the product shifts a schedule B number in the Chapter or sub chapter level,due to intended use or processing, the product now "originates" the US according to NAFTA and other trade rules.

10 posted on 05/01/2008 6:00:57 AM PDT by NativeSon (off the Rez without a pass...)
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